EVALUATION OF VTMs
Last updated: 19 March 2021
The Research Institute for Tropical Medicine (RITM), as the National Reference Laboratory, is mandated to perform the evaluation of commercially-manufactured in vitro diagnostic medical devices, in collaboration with the Philippine Food and Drug Administration (FDA).
The huge increase in testing has put pressure on the laboratory supply chain and resulted in shortages of viral transport media (VTM). In support of the national COVID-19 response, the Institute has undertaken evaluation of laboratory test kits as well as VTM and swabs.
Evaluation of the VTM is done by infecting the swabs with known Influenza A and Influenza B clinical samples and is subsequently submerged into the VTM. The VTM is tested in parallel with commercially available swab/VTM combinations (reference kit) for Real-time PCR detection of Influenza following WHO recommended protocol. Acceptability of the product is dependent on the generated PCR values if comparable with the reference kit.
Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.
|#||Transport Media||Manufacturer||Catalog number||Passed||Date Performed|
|1||Universal Transport Medium (UTM)||Copan, USA||305C||P||2014|
|2||Sansure sample storage reagent||Sansure Biotech Inc.||P||March 31|
|3||Biologix transport media||Biologix Group Limited||P||April 4|
|4||Sanli Virus specimen collection tube||Liuyang, Sanli Medical Technology Devt. Co||P||April 9|
|5||Asan Universal Transport Medium||Puritan Medical Products Co. LLC||P||April 28|
|6||Noble Bio Universal Transport Medium||Noble Biosciences Inc.
Clinical Diagnostics Products
|7||Dewei RNA preservation kit||Dewei Medical Equip. Co. Ltd.||P||May 5-6|
|8||Biocomma transport and preservation medium||Biocomma Limited Ltd.||P||May 5-6|
|9||Genesis transport media||Genesis Lifetech Marketing||P||May 6-7|
|10||Remel MicrotestTM M6TM Transport media||Thermo Fisher Scientific||P||May 5-6|
|11||VTMTek Pack||Manila HealthTek, Inc.||P||May 6-7|
|12||Date Bioengineering specimen preservation reagent||Guangzhou Date Bioengineering Technology Co., Ltd.||P||May 23-26|
|13||Citotest Labware Manufacturing Co., Ltd.||Guangzhou Date Bioengineering Technology Co., Ltd.||P||May 23-26|
|14||Kangjian Virus Collection and Preservation system||Jiangsu Kangjian Medical Apparatus CO.,Ltd.||P||June 24- 25|
|15||Suntrine Viral Transport Medium with swab||Taizhou Sun Trine Biotechnology Co., Ltd||902101||P||June 24- 25|
|16||Specimen Collection Kit With Flocked Swab||Vegas Biotech||P||June 24- 25|
|17||Hi Viral Transport Medium||HiMedia Laboratories Pvt. Ltd||P||July 16-20|
|18||Virus Sampling Tube (Type 1 –Activated)||Hebei Chaoran Medical Instruments Co. LTD.||CR502-19A (Type 1 –Activated)
CR502-19C (Type 2 –Inactivated)
|19||Disposable Sample Collection Kits||Nodford International Co., LTD||NFV-101||P||September 18|
|20||Linger Virus Sampling Tube||Lingen Precision Medical Products (Shanghai) Co. Ltd.||MTM-04, T01||P||September 18|
|21||Purflock Ultra Sterile Flocked Collection Device||Puritan Medical Products Company||25-3317-U||P||September 28|
|22||Zybio Disposable Virus Sampling Tube||Zybio Inc.||VTM:Inactivated10ml-2||P||September 28|
|23||Biologix Transport and Preservation Medium (classic and inactivated)||Biologix Group Limited||19-1301 (Classic) ; 19-1302 (Inactivated)||P||October 12|
|24||Babio Virus Transport Kit (Non-Inactivated)||Jinan Babio Biotechnology Co., Ltd.||D384564||P||October 12|
|25||Bioteke Disposable Virus Sampling Kits (Activated and Inactivated)||Bioteke Corporation Co., Ltd.||ST-9001-1 (Activated) ;ST8001-1 (Inactivated)||P||October 30|
|26||Bruner Disposable Specimen Collection Tube||Liuyang SANLI Medical Technology Development Co., Ltd.||SL901B||P||October 30|
|27||Prime Store Molecular Transport Medium (MTM)||Longhorn Vaccines and Diagnostics LLC||Prime Store MTM 3ml||P||November 11|
|28||NEST Disposable Sampler (Inactivation Transport Medium and Virus Transport Medium)||Wuxi NEST Biotechnology., LTD||202038 (Inactivation Transport Medium)
202018 (Virus Transport Medium)
|29||MANTACC Disposable Sampling Kit||Miraclean Technology Co. Ltd.||MANTACC-UTM10.0||P||December 2|
|30||1st Base Viral Transport Media||Apical Scientific||CUS-7020-3ml||P||December 9|
|31||Longsee One-off Sampling tube||Guangdong Longsee Biomedical Co., Ltd||3mL/T||P||December 9|
|32||Shandong Chengwu Medical disposable virus specimen collection||Shandong Chengwu Medical Products Factory||P||December 15|
|33||CDRICH Single Use Virus Specimen Collection Tube.||Chengdu Rich Science Industry Co., Ltd.||Type I (with inactivator)||P||December 15|
|34||bioBoaVista (BBV) Viral Transport Media (VTM)||bioBoaVista, Valinhos, Sao Paulo Brazil||P||January 6, 2021|
|35||Citoswab Virus Collection and Transport Kit||Citotest Labware Manufacturing Co., Ltd.||2118-1524-99||P||January 26, 2021|
|36||Citoswab flocked swab||Citotest Labware Manufacturing Co., Ltd.||Ref. No.:20609017||P||January 26, 2021|
|37||Citoswab flocked swab||Citotest Labware Manufacturing Co., Ltd.||Ref. No.:20609017||P||January 26, 2021|
|38||BioSci Disposable Virus Sampling Tube||Shenzen Dakewe Bio-engineering Co. Ltd.||Classic (Catalogue No. FBY)
Inactivated (Catalogue No. MBY)
|P||February 09, 2021|
|39||BD Universal Viral Transport Medium||Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152 USA BENEX Limited Shannon, County Clare, Ireland||Catalogue No. 220220||P||March 04, 2021|
|40||Bioer Viral Transport Medium||Nippon Genetics Co., Ltd. Koraku Mori Bldg.,18F, 4-14 Koraku 1-Chome, Bunkyo-ku, Tokyo, 112-0004, Japan||Catalogue No. BSC85X1-B1||P||March 04, 2021|
Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).
The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.